Abstract: A device (10) for delivering a fluid includes a housing (12) defining an interior space (22) and having a bottom surface (18) configured for contacting a patient. The bottom surface (18) defines a needle opening (56). The device (10) also includes a reservoir (26) disposed within the interior space (22) of the housing (12) for containing a fluid therein, a needle carrier (30) disposed within the housing (12), and an injection needle (28) supported by the needle carrier (30) and defining a lumen. The lumen of the injection needle (28) is configured to be placed in fluid communication with the reservoir (26).

Abstract: A method for creating a sterile connection with a fluid in a container. The container has a sealing member sealing a first end of the container, and a barrier sealing a chamber in fluid communication with the sealing member. The method includes providing a valve sleeve assembly that includes a flexible sleeve having a barrier portion at an end of the flexible sleeve, a hollow first penetrator disposed within the flexible sleeve, and a hollow second penetrator at least partially disposed within the first penetrator. An interior of the flexible sleeve is sterile. The method also includes piercing the barrier portion and the barrier with the first penetrator, and displacing the second penetrator relative to the first penetrator and the sealing member to pierce the sealing member and establish the sterile connection with an interior of the container.

Abstract: An injection pen (1) includes a housing (2), a lead screw (75), a dose set member (6), a setback member (17), and a rotatable driver (60). The lead screw (75) is axially moveable in the housing (2). The dose set member (6) is connected to the housing (2) for dose setting and dose correcting. The setback member (17) is operatively connected to the dose set member (6). The rotatable driver (60) is operatively connected to the setback member (17) and the lead screw (75). The driver (60) is prevented from rotating during dose setting and dose correcting, and the driver (60) rotates during an injection to axially move the lead screw (75).

Abstract: An injection pen, comprising a housing, a lead screw axially moveable in the housing, a dose set member for dose setting and dose correcting, threadably connected to the housing and having a first mating feature, a setback member having a second mating feature for engaging the first mating feature, a clicker that generates an audible or tactile indication during operation, the clicker being operatively connected to the dose set member, and a push button operatively connected to the setback member to cause the second mating feature to engage the first mating feature during an injection, the push button receiving the clicker, wherein the first mating feature is disengaged from the second mating feature during dose setting and dose correcting and engaged with the second mating feature during an injection.

Abstract: An injection pen (1) includes a housing (2), a lead screw (75), a dose set member (6), a setback member (17), and a rotatable driver (60). The lead screw (75) is axially moveable in the housing (2). The dose set member (6) is connected to the housing (2) for dose setting and dose correcting. The setback member (17) is operatively connected to the dose set member (6). The rotatable driver (60) is operatively connected to the setback member (17) and the lead screw (75). The driver (60) is prevented from rotating during dose setting and dose correcting, and the driver (60) rotates during an injection to axially move the lead screw (75).

Abstract: An adapter assembly for establishing bidirectional fluid connection between a cartridge and a vial includes a housing having an open first end adapted to engage the cartridge and a second open end adapted to engage the vial. The adapter includes a needle assembly having a first tip and a second tip, with the needle assembly disposed within the housing and at least partially supported by a needle holder. The needle assembly is movable relative to the housing from an initial position in which the first and second tip are isolated from the cartridge and vial, to an end of use position, in which first tip is engaged with the vial and the second tip is engaged with the cartridge, establishing fluid communication therebetween. The needle assembly is maintained in the initial position by a locking structure which is released by rotationally advancing the needle holder relative to the housing.

Abstract: A medical injector has a body with a displaceable plunger. The plunger includes a plurality of spaced-apart ratchet teeth disposed along the length thereof. At least one indexer is provided to engage the plunger, wherein the indexer is configured to allow the plunger to displace distally toward a distal end of the body but not proximally toward a proximal end of the body. The medical injector also includes an actuator having an engagement portion formed to engage one or more of the ratchet teeth. The actuator is displaceable to a ready state, the engagement portion being displaced proximally relative to the plunger with the actuator being displaced to the ready state. The indexer prevents proximal movement of the plunger, thereby allowing the engagement portion to bypass one or more of the ratchet teeth with the actuator being displaced to the ready state. In addition, the actuator is displaceable from the ready state to cause actuation of the medical injector.

Abstract: A system for medication delivery comprises a Package containing a medication and a Dosing mechanism for delivering a dose of a drug, formulated as multiparticulate, microspheres, powder or liquid. The Package comprises a bottle, a bottle insert that covers the bottle opening and includes a dispense nozzle. The dispense nozzle is sealed using a valve that opens when the Dosing device is engaged with the bottle. A closure covers the bottle insert and closes the bottle. The Dosing device, similar to an oral syringe, comprises a barrel with a valve at its distal end, a plunger and a dose control clip for attachment to the plunger. After the dosing device is connected to the bottle valve, withdrawal of the plunger causes the dosing device to receive a dose of drug, the user pushes the plunger which pushes the MP drug through the valve and into a patient's mouth.

Abstract: A medication injection pen, including a housing, a dose set knob (DSK) comprising an internal thread and an internal key proximate to a distal end of the internal thread, and a dose stop member comprising an external thread engaging the internal thread of the dose set knob. Rotation of the dose set knob to set a medication dose causes lateral translation of the dose stop member with respect to the dose set knob, and when the dose set knob is rotated to a last dose setting position, the dose stop member rotationally abuts the internal key thereby preventing further rotational movement of the dose set knob in a dose setting direction.

Abstract: A medication injection pen, comprising a housing, a dose set knob that rotates with respect to the housing during dose setting and dose correcting, and a driver selectively engaged with the dose set knob, the driver rotatably fixed with respect to the housing during dose setting and dose correcting, wherein the driver moves axially with the dose set knob during dose setting and dose correcting, and the driver rotates with the dose set knob during an injection.

Abstract: A removal device (121, 221) for removing and disposing of a pen needle (113, 213) connectable to a drug delivery device (111, 211) includes a body (123, 223) having a cavity (141, 241) for receiving the pen needle of the drug delivery device such that a patient end (116, 216) of a needle (115, 215) of the pen needle is covered by the body. An ejector (151, 251) is movably connected to the body (123, 223) for engaging the received pen needle (113, 213) and selectively ejecting the engaged pen needle from the body. The pen needle (113, 213) is securely retained within the removal device (121, 221) without exposing the needle (115, 215) of the pen needle until the pen needle (113, 213) can be properly disposed of, such as in a sharps container, thereby substantially preventing an accidental needle stick.

Abstract: A system including an adapter (14) for sequential engagement with a cartridge (18) containing a first substance and a vial (16) containing a second substance is disclosed. The adapter is configured to first engage with the vial and subsequently engage with the cartridge such that the cartridge is in fluid communication with the vial via the adapter. The system includes a latch member (150) engageable with a portion of the cartridge. A plunger rod (44) includes a protrusion (50) and is adapted to communicate with the latch member, the plunger rod being transitionable from a disengaged position, in which the protrusion of the plunger rod is disengaged from the latch member and the latch member is locked to the cartridge, to an engaged position, in which the protrusion is engaged with the latch member and the latch member is unlocked from the cartridge and locked to the plunger rod.

Abstract: A medication injection pen, including a housing, a push button, a dose set knob (DSK) including at least one internal tooth and a ring of DSK ratchet teeth, a driver including at least one external tooth and a ring of driver ratchet teeth, a clicker operatively engaged between said dose set knob and said driver having at least a DSK ratchet arm and at least a driver ratchet arm, wherein said driver is prevented from rotating with said dose set knob while moving axially with said dose set knob during dose setting and dose correcting, and when said push button is depressed, said clicker pushes said driver distally such that said at least one external tooth of said driver engages said at least one internal tooth of said dose set knob thereby forcing said driver to rotate with said dose set knob during an injection.

Abstract: A removal device (121, 221) for removing and disposing of a pen needle (113, 213) connectable to a drug delivery device (111, 211) includes a body (123, 223) having a cavity (141, 241) for receiving the pen needle of the drug delivery device such that a patient end (116, 216) of a needle (115, 215) of the pen needle is covered by the body. An ejector (151, 251) is movably connected to the body (123, 223) for engaging the received pen needle (113, 213) and selectively ejecting the engaged pen needle from the body. The pen needle (113, 213) is securely retained within the removal device (121, 221) without exposing the needle (115, 215) of the pen needle until the pen needle (113, 213) can be properly disposed of, such as in a sharps container, thereby substantially preventing an accidental needle stick.

Abstract: An injection device (100), including a base (104), a sliding body (116) slidably connected to the base (104), a double-ended needle (120) fixed to the sliding body (116), a biasing member (124) for proximally biasing the sliding body (116) with respect to the base (104), and for retracting the needle (120) into the device (100) subsequent to activation of the device (100), a medicament cartridge (128) for holding a medicament, slidably connected to the sliding body (116), and a stopper (132) slidably disposed within the medicament cartridge (128). The base (104) has a proximal end (108) and a surface (164) disposed at a distal end (112) thereof for contacting a patient's skin. The base (104) also has a first locking mechanism. The sliding body, (116) has a locking feature and a second locking mechanism. The second locking mechanism locks the medicament cartridge (128) relative to the sliding body (116) upon completion of displacement of the medicament cartridge (128) relative to the sliding body (116).

Abstract: A medication injection pen comprises a dose set knob rotatable with respect to a housing to set a desired injection dose. The dose set knob comprises at least one internal thread. A leadscrew includes a thread element for advancing in a first direction via a corresponding thread engagement. A driver is rotationally fixed to the leadscrew and is rotatable in a first direction to rotate and advance the leadscrew in the first direction. The setback member is rotationally fixed to the driver. The dose stop member is rotationally coupled to the setback member and is axially movable relative to the dose set knob when the dose set knob is rotated relative to the setback member. Axial movement of the dose stop member limits the user from setting a dose that is greater than an injectable volume of medication remaining in a cartridge.

Abstract: A medication injection pen (50) includes a housing (1) and a dose set knob (2) rotatably connected to the housing (1) for setting a dose. An indicator member (200) is movable between a visible position indicating a zero position of the dose set knob (2) and a non-visible position indicating a non-zero position of the dose set knob (2). The indicator member is visible to a user in the visible position and not visible to the user in the non-visible position. The dose set knob is in the zero position when a set dose has been completely administered. Accordingly, a visible indication is provided to the user when a set dose has been completely administered.

Abstract: A medication injection pen is provided comprising a housing (218), for housing a dose set knob (220), a leadscrew (226), a driver (224), a setback member (222), and a dose stop member (228). The dose set knob (220) is rotatable with respect to said housing (218) to set a desired injection dose, and comprises at least one internal thread (291). The leadscrew (226) includes a thread element by which it is advanceable in a first direction via a corresponding thread engagement, said first direction being that which expels medication from a cartridge (36). The driver (224) is rotationally fixed to said leadscrew (226) for preventing relative rotation therebetween, said driver (224) being rotatable in a first direction to rotate and advance said leadscrew (226) in said first direction. The setback member (222) is rotationally fixed to said driver (224) for preventing relative rotation therebetween.

Abstract: A self-injection device (100, 200), including a pen body (108, 208) connectable to a pen needle (10), and a cap (104, 204) selectively connectable to the pen body (108, 208) in a first orientation with respect to the pen body (108, 208) to minimize the length or volume of the self injection device (100, 200), and in a second orientation to provide sufficient length or volume in an interior of the cap (104, 204) to house a pen needle (10) connected to the pen body (108, 208).

Abstract: A cartridge for containing and dispensing a medicament, the cartridge including a cartridge body having an interior cavity therein, a stopper movably disposed within the interior cavity, and a septum disposed at an opposite end of the interior cavity from the stopper, for containing the medicament within the interior cavity. The cartridge also includes a connection thread integrally formed as a unitary construction of the cartridge body, the thread being disposed at a first end of the cartridge body for connecting a pen needle directly to the cartridge body to pierce the septum and provide communication between the medicament and a patient end of the pen needle.